JJF 1542-2015 English PDF

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JJF 1542-2015: Calibration Specification for SpO2 Simulator
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Basic data

Standard ID: JJF 1542-2015 (JJF1542-2015)
Description (Translated English): Calibration Specification for SpO2 Simulator
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A50
Classification of International Standard: 17.020
Word Count Estimation: 14,190
Date of Issue: 2015-08-24
Date of Implementation: 2015-11-24
Quoted Standard: JJF 1059.1-2012
Regulation (derived from): AQSIQ Announcement 2015 No.106
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine
Summary: This Standard applies to the photoelectric pulse oximetry simulator calibration.

JJF 1542-2015: Calibration Specification for SpO2 Simulator

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Oxygen saturation simulation Calibration Specification) People's Republic of China National Metrology Technical Specifications Oxygen saturation simulation Calibration Specification Issued on. 2015-08-24 2015-11-24 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Oxygen saturation simulation Calibration Specification SpO2Simulator Focal point. the National Technical Committee on Medical Measurement The main drafting units. China Institute of Metrology Participated in the drafting unit. Beijing Medical Technology Co., Ltd. is satisfied that male People's Liberation Army General Logistics Department of the Ministry of Health and Drug Control Chinese Academy of Sciences Institute of Optical Technology Fluke test equipment (Shanghai) Co., Ltd. This specification entrusted to the National Technical Committee is responsible for interpreting medical measurement The main drafters of this specification. Pu Zhang (China Institute of Metrology) Sun Jie (China Institute of Metrology) Drafters participate. Shaw Magpie (Beijing Medical Technology Co., Ltd. is satisfied male) Hongbao Yu (China Institute of Metrology) Jia Jiange (People's Liberation Army General Logistics Department of the Ministry of Health and Drug Control) Shi Guohua (Institute of Optoelectronic Technology Institute) Cui smile (Fluke test equipment (Shanghai) Co., Ltd.)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2. References (1) 3 terminology and units of measurement (1) 3.1 oximetry (value) (1) 3.2 R value (1) 3.3 R value of the curve (1) 3.4 pulse rate (value) (1) 4 Overview (1) 5 Metrological characteristics (1) 5.1 oximetry value (1) 5.2 pulse frequency (2) Calibration Condition 6 (2) 6.1 environmental conditions (2) 6.2 standards and other measuring equipment (2) 7 Calibration methods and calibration items (2) 7.1 appearance and function check (2) 7.2 oxygen saturation values (2) 7.3 pulse frequency indication error (3) 8 calibration results expression (3) 9 Recalibration interval (4) Appendix A simulation of oxygen saturation Calibration original records (recommended) formatting styles (5) Appendix B calibration certificate within the page (recommended) formatting styles (6) Appendix C oxygen saturation calibration value of Uncertainty Evaluation Example (8)

Introduction

Preparation of this specification to JJF 1071-2010 "National Calibration Specifications writing rules", JJF 1001-2011 "General measurement terms and definitions", JJF 1059.1-2012 "Evaluation and Expression of Uncertainty in Measurement" basis and in accordance with. The specification for the first time to develop. Oxygen saturation simulation Calibration Specification

1 Scope

This standard applies to the photoelectric pulse oximetry simulator calibration. 2. References This specification references the following documents. JJF 1059.1-2012 Evaluation and Expression of Uncertainty in Measurement For dated references, only the dated edition applies to this specification; undated reference documents Member, the latest edition (including any amendments) applies to this specification.

3 terminology and units of measurement

3.1 oximetry (value) oxygensaturation (value) Oxygen saturation (SpO2) in the blood is bonded to oxygen oxyhemoglobin (HbO2) of the total capacity available The combined percentage of hemoglobin (Hb) capacity. 3.2 R value Rvalue Red and infrared light absorbed by human tissue ratio after. Pulse oximeter obtained based on the ratio calculation Body arterial oxygen saturation values. 3.3 R value curve Rvaluecurves Correspondence between the R value and the oxygen saturation values is called the R value of the curve, NECOLLOR, BCI and MASI- MO is one of three most common R-value curve. 3.4 pulse rate (value) pulserate (value) The number of beats per minute arteries. Unit. beats/min.

4 Overview

Oximetry simulator (hereinafter referred to as "simulator") simulate the human values of oxygen saturation and pulse rate values, And it can be used to detect the pulse oximeter and multi-parameter monitor blood oxygen saturation in the module. Analog simulation of the optical instrument Composition means and the host of two parts, optical simulation refers to the lower surface is equipped with two optical sensors are used to detect red and infrared Optical signal; the upper surface is provided with a light emitter. Simulator work, refers to optical analog light sensor receives light signals Forming two pulse after pulse as a trigger signal to the host, the host according to the parameters menu settings to control light emission Light signals emitted by the optical signal acquisition and prior to the trigger signal synchronization, simulated light transmitted through a human finger After the light attenuation. Controlled optical signal simulator output pulse oximeter was measured after the pulse oximetry And of the corresponding instrument available oxygen saturation and pulse frequency values.

5 Metrological characteristics

5.1 oxygen saturation values ......

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